Apokyn Injection
NDC Package 27505-004-05

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Apokyn (apomorphine hydrochloride) injection is a medication used to treat the symptoms of Parkinson's disease. This formulation utilizes a injection delivery system. Marketed by Mdd Us Operations, Llc, this product is identified by NDC 27505-004 and is authorized under FDA application NDA021264.

Identification & Billing

NDC Package Code
27505-004-05
Package Description
5 CARTRIDGE in 1 CARTON / 3 mL in 1 CARTRIDGE (27505-004-01)
Product Code
27505-004
11-Digit Billing Format
27505000405
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Apokyn
Non-Proprietary Name
Apomorphine Hydrochloride
Substance Name
Apomorphine Hydrochloride
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
APOMORPHINE HYDROCHLORIDE 30 mg/3mL
Pharmacologic Class
Usage Information
This medication is used to treat the symptoms of Parkinson's disease. It can improve your ability to move during frequent "off" periods. It can decrease shakiness (tremor), stiffness, slowed movement, and unsteadiness. This medication is thought to work by helping to restore the balance of a certain natural substance (dopamine) in the brain. Apomorphine is used to treat "off" episodes when they occur. It is not used to prevent "off" episodes. This drug should not be used instead of your usual medications for Parkinson's disease. Continue taking all your medications as directed by your doctor.

Regulatory & Marketing

Labeler Name
Mdd Us Operations, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA021264
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-02-2004
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 27505-004-05 identifies a specific commercial package of 5 cartridge in 1 carton / 3 ml in 1 cartridge (27505-004-01) of Apokyn, a human prescription drug labeled by Mdd Us Operations, Llc. This injection is formulated for subcutaneous use and contains apomorphine hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Mdd Us Operations, Llc on July 02, 2004. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat the symptoms of Parkinson's disease. It can improve your ability to move during frequent "off" periods. It can decrease shakiness (tremor), stiffness, slowed movement, and unsteadiness. This medication is thought to work by helping to restore the balance of a certain natural substance (dopamine) in the brain. Apomorphine is used to treat "off" episodes when they occur. It is not used to prevent "off" episodes. This drug should not be used instead of your usual medications for Parkinson's disease. Continue taking all your medications as directed by your doctor.

How is this Mdd Us Operations, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 27505000405. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
27505-004-05
11-Digit CMS (5-4-2)
27505-0004-05

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.